A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
NCT ID: NCT01605825
Last Updated: 2016-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2012-05-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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placebo/dalfampridine-ER
Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:
Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
placebo/dalfampridine-ER
Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
dalfampridine-ER/placebo
Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:
Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
dalfampridine-ER/placebo
Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Interventions
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placebo/dalfampridine-ER
Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
dalfampridine-ER/placebo
Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Eligibility Criteria
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Inclusion Criteria
* ≥ 6 months post-stroke
* Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive
* Stable concomitant medication therapy regimen within 4 weeks of screening visit
Exclusion Criteria
* Moderate or severe renal impairment as defined by a calculated creatinine clearance of ≤ 50 mL/minute using the Cockcroft-Gault Equation
* Botulinum toxin use within 2 months prior to the Screening Visit
* Orthopedic surgical procedures in any of the extremities within the past 6 months
* Diagnosis of multiple sclerosis
18 Years
85 Years
ALL
No
Sponsors
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Acorda Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Mathews Adera, MD
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
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Acorda Site #011
Birmingham, Alabama, United States
Acorda Site #018
La Jolla, California, United States
Acorda Site #016
Newport Beach, California, United States
Acorda Site #006
Fairfield, Connecticut, United States
Acorda Site #002
Atlantis, Florida, United States
Acorda Site #015
Fort Lauderdale, Florida, United States
Acorda Site #003
Decatur, Georgia, United States
Acorda Site #021
Lexington, Kentucky, United States
Acorda Site #009
Boston, Massachusetts, United States
Acorda Site #017
Saginaw, Michigan, United States
Acorda Site #020
Great Falls, Montana, United States
Acorda Site #023
Reno, Nevada, United States
Acorda Site #022
New Brunswick, New Jersey, United States
Acorda Site #019
Buffalo, New York, United States
Acorda Site #007
West Haverstraw, New York, United States
Acorda Site #004
White Plains, New York, United States
Acorda Site #013
Charlotte, North Carolina, United States
Acorda Site #001
Philadelphia, Pennsylvania, United States
Acorda Site #008
Norfolk, Virginia, United States
Acorda Site #010
Bellevue, Washington, United States
Countries
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References
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Iaci JF, Parry TJ, Huang Z, Finklestein SP, Ren J, Barrile DK, Davenport MD, Wu R, Blight AR, Caggiano AO. Dalfampridine improves sensorimotor function in rats with chronic deficits after middle cerebral artery occlusion. Stroke. 2013 Jul;44(7):1942-50. doi: 10.1161/STROKEAHA.111.000147. Epub 2013 May 7.
Other Identifiers
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DALF-PS-1003
Identifier Type: -
Identifier Source: org_study_id
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